Kornimate/medical-research-clean huggingface dataset:
effects of nicorandil on cardiac infarct size in patients with st-segment elevation acute myocardial infarction

Conditions: Myocardial Infarction

Summary: the purpose of this study is to determine whether nicorandil reduce cardiac infarct size in patient with st-segment elevation acute myocardial infarction.

study objective : to investiage whether nicorandil treatment reduce infarct size measured by cardiac mri at 6 months after primary pci allocation : 1. nicorandil arm : recieve nicorandil 4 mg i.v. before undergoing pci, additionall 2mg i.c. just before 1st ballooning, additionall 2mg i.c. just before stenting, after successful pci, 10 mg/day (or 5 mg/day) p.o. for 6 months. 2. control arm : recieve standard treatment including pci, but avoid nicoranil and adenosine. follow-up and measurement : cardiac mri scans are scheduled at 5 days and 6 months after primary pci. clinically followed upto 6 months after parimary pci.

Eligibility criteria:
inclusion criteria: * stemi patients presenting within 12 hours after symptom onset * undergoing primary pci exclusion criteria: * previous myocardial infarction * atrial fibrillation * rv infarction * cardiogenic shock * serum creatinine \>2.0 mg/dl * narrow angle glaucoma * taking pde-5 inhibitors

Keywords: nicorandil cardiac mri
melody transcatheter pulmonary valve study: post approval study of the investigational device exemption cohort

Conditions: Congenital Heart Defects; Dysfunctional Right Ventricular Outflow Tract Conduits

Summary: the primary objective is to confirm the long-term functionality of implantation of the medtronic melody tpv at 5 years is no worse than the historical control established through literature review. the secondary objectives are to evaluate long-term functionality at 10 years and to assess safety, procedural success, and clinical utility of transcatheter implantation of the melody tpv.

the primary objective is to confirm the long-term functionality of implantation of the medtronic melody tpv at 5 years is no worse than the historical control established through literature review. the secondary objectives is to evaluate long-term functionality at 10 years and to assess safety, procedural success, and clinical utility of transcatheter implantation of the melody tpv.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 5 years of age * weight greater than or equal to 30 kilograms * existence of a full (circumferential) rvot conduit that was equal to or greater than 16 mm in diameter when originally implanted, or a stented bioprosthesis with a rigid circumferential sewing ring in the rvot that has an internal diameter greater than or equal to 18 mm and less than or equal to 22 mm when originally implanted. * any of the following by transthoracic echocardiography: * for patients in new york heart association (nyha) classification ii, iii, or iv: moderate (3+) or severe (4+) pulmonary regurgitation and/or mean rvot gradient greater than or equal to 35 mmhg * for patients in nyha classification i:severe (4+) pulmonary regurgitation with rv dilatation or dysfunction and/or mean rvot gradient greater or equal to 40 mmhg exclusion criteria: * active endocarditis * major or progressive non-cardiac disease (liver failure, renal failure, cancer)that has a life expectancy of less than one year * patient or guardian unwilling or unable to provide written informed consent or comply with follow-up requirements * obstruction of the central veins (including the superior and inferior vena cava, bilateral iliac veins) such that the delivery system cannot be advanced to the heart via transvenous approach from either femoral vein or internal jugular vein * positive urine or serum pregnancy test 24 hours prior to procedure in female patients of child bearing potential * known intravenous drug abuse
study to evaluate the safety and efficacy of the citop™ expander™ guidewire for crossing chronic total occlusions in coronary arteries

Conditions: Coronary Chronic Total Occlusion

Summary: a multicenter multinational study to evaluate the safety and efficacy of the citop™ expander™ guidewire for crossing chronic total occlusion in coronary arteries.


Eligibility criteria:
inclusion criteria: 1. informed consent obtained prior to any trial activities. 2. patients, male or female between 21 and 80 years of age, with no significant co-morbidities (see exclusion criteria). 3. patient has an angiographic documented chronic total occlusion showing distal timi flow 0 to 1. exclusion criteria: 1. patient unable to give informed consent. 2. current participation in another study with any investigational drug or device. 3. factors making follow-up and/or repeat angiography difficult or unlikely. 4. contra-indication to emergency artery by pass surgery. 5. lack of surgical backup. 6. contra-indication to treatment with aspirin, or clopidogrel and/or heparin. 7. lesion \> 40mm in length (both calcified lesion and adjacent thrombus). 8. treated vessel referenced diameter less than 2.5 mm. 9. visualization of the distal lumen less than the rentrop classification grade 2 collateralization. 10. non-visible entry point of target lesion. 11. totally occluded bypass graft as target vessel. 12. acute mi less than 1 week before procedure. 13. patient has significant lv dysfunction, 35% lvef or less. 14. patient with cancer or other sever chronic disease with life expectance of 2 years. 15. patient has chronic renal failure with serum creatinine ≥2. 16. hemoglobin ≤11. 17. patient is known or suspected not to tolerate the contrast agent. 18. morbid obesity (bmi \> 40). 19. drug abuse or alcoholism. 20. patients under custodial care. 21. pregnant women or women with childbearing potential with a positive pregnancy test at the time of procedure.

Keywords: cto chronic total occlusion revascularization
tamoxifen for progressive transitional cell carcinoma following previous chemotherapy treatment

Conditions: Urinary Bladder Neoplasms

Summary: the major objective of this two-stage phase ii study is to determine whether tamoxifen is deserving of further study in metastatic bladder cancer. tamoxifen is expected to function as a cytostatic (and not cytotoxic) agent, and may produce more disease stability than regression. sustained stable disease is considered to be clinically important and the more likely event. hence, 4-month freedom from progression is chosen as the primary end-point instead of response rate. freedom from progression is defined as the period from start of therapy to the time of objective radiologic progression. a total of 25 subjects will be enrolled, 15 during stage 1 and 10 during stage 2 of a two-stage minimax design phase ii study. pre-therapy evaluation (within 3 weeks of initiation of therapy): * history and physical examination (h and p) * performance status (ps) assessment * cbc (complete blood counts) * cmp (complete metabolic profile) * pregnancy test (in women younger than 50) * computed tomography (ct) scan of the chest, abdomen and pelvis * bone scan if bone pain or raised alkaline phosphatase * biopsy (may use previous biopsy specimen) * samples of plasma from the routine cbc and cmp will be banked indefinitely for future biomarker studies at the scott department of urology. treatment plan: therapy will be administered as an outpatient. tamoxifen is administered at 20 mg/day as a single daily oral dose. clinical assessment of patients by a history and physical examination will be performed every 4 weeks (one cycle). objective radiological assessment of response will be made every 8 weeks or earlier if clinically indicated. a ct (computerized tomography) scan of the abdomen, pelvis and chest will be performed at baseline and every 2 cycles. a response is confirmed by repeating the scans in 4 weeks. bone scan is performed if the patient complains of new bone pain or has raised alkaline phosphatase. a radiologist who is blinded to the treatment regimen reads the scans. the recist criteria are used to define response. tamoxifen is continued until progressive disease or intolerable side effects occur.


Eligibility criteria:
inclusion criteria: * patients previously diagnosed with bladder cancer who have already received 1-2 systemic therapy regimens (chemotherapy or biological therapy or both) but including at least one chemotherapy regimen. * patients who have had the cancer spread to other parts of the body. * patients must have adequate liver function. exclusion criteria: * patients who have uncontrolled nervous system metastasis * patients who are pregnant * patients who have had systemic therapies within the past 4 weeks * patients who plan to have major surgery within 2 weeks * patients who have grade iii/iv heart problems * patients who have severe and/or uncontrolled medical disease. * patients who might be at high risk for deep vein thrombosis

Keywords: urinary bladder neoplasms previous chemotherapy tamoxifen anti-tumor activity
etiology and early diagnosis of neurodevelopmental disorders

Conditions: Neurodevelopmental Disorders

Summary: the purpose of this study is to systematically evaluate the results of medical investigations to identify symptom and biological patterns and common etiologies of neurodevelopmental disorders.

although neurodevelopmental disorders are very prevalent (for example autism affects 1 out of every 88 children and dyslexia affects up to 15% of the population), the etiology of such disorders is not known. the purpose of this investigation is to identify common etiologies of neurodevelopmental disorders (i.e., speech delay, global developmental delay, autism) and determine if it is possible to find early indicators of the diagnosis and foster the potential for a better prognosis of these disorders. at this time the investigators examine patients with neurodevelopment disorders with various medical investigations, but the results of these investigations are not systematically evaluated. one of the goals of this research is to systematically examine this information in order to identify patterns of test abnormalities that have not been previously described. another goal of this research is to identify the common etiologies typically identified by the medical evaluation, so we can further refine our approach. in addition, the investigators now have the ability to evaluate biological samples for biomarkers that have potential to be diagnostically useful.

Eligibility criteria:
inclusion criteria: * neurodevelopmental delays * clinical visit at an arkansas children's hospital outpatient clinic exclusion criteria: * none

Keywords: autism autism spectrum disorder (asd) pervasive developmental disorder (pdd) developmental delays genetic disorder mitochondrial disorder
improving outcomes of respiratory patients with exertional hypoxemia

Conditions: Pulmonary Rehabilitation

Summary: the primary aim of this pilot randomized controlled trial is to determine feasibility of the proposed pulmonary rehabilitation intervention.

in this pilot randomized controlled trial, our primary aim is to determine feasibility of the proposed intervention.

Eligibility criteria:
inclusion criteria: * 21 years and above * presence of exertional hypoxemia during 1-minute sit-to-stand test * diagnosis of acute copd exacerbation or covid-19 pneumonia or exacerbation of bronchiectasis or exacerbation of interstitial lung disease * physically fit to participate in exercise therapy as determined by both the patient's physician and physiotherapist exclusion criteria: * uncontrolled severe medical conditions * currently enrolled in a pulmonary rehabilitation trial * unsuitable for randomization as determined by the patient's physician
a pilot study testing the efficacy of a needling device for the treatment of acne scars

Conditions: Acne Scars

Summary: the primary objective of this study is to determine the efficacy of a needling device for treatment of acne scars.

we are investigating a needled micro-roller for use in improving the appearance of acne scars. the study is being conducted under the direction of dr. murad alam of northwestern university, department of dermatology. the needles on the micro-roller are designed to create small holes in the top and mid layers of skin in order to induce the formation of more collagen, which would in turn help improve the appearance of acne scars. to qualify for the study, you must have at least 2 large areas of the face with acne scars. the study is designed such that one part of your face, which has acne scars, will be treated with the device on 3 separate occasions, spaced 2 weeks apart at our clinic in chicago at northwestern. we would also ask you to return at 3 months and at 6 months to have photographs taken. if you are interested in participating, we would like to get you involved as soon as possible

Eligibility criteria:
inclusion criteria: * ages 18-70 years old * subjects in general good health * the subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator * global acne scarring classification grade 2-41 (appendix ii) * subject has at least two areas of acne scaring on the face (with at least 2 acne scars in each) that are at least 2 cm apart exclusion criteria: * pregnancy and lactation * subjects with history of keloid or hypertrophic scars * subjects with active skin disease (other than mild acne) or skin infection in the treatment area * subjects with an active systematic or local skin disease that is likely to alter wound healing * subjects who have undergone in the past 6 months or planning to undergo in the next 6 months the following cosmetic treatments in the acne scar area * injectable permanent filler * ablative laser treatment * subjects taking the following prescription medications: * accutane or other retinoids within the past 12 months * anticoagulant (warfarin) * subjects who allergic to lidocaine and prilocaine
a randomized trial of intracoronary reopro to improve coronary microvascular function

Conditions: Myocardial Infarction; Coronary Artery Disease

Summary: microvascular dysfunction is a key determinant of pathogenesis and outcome in patients suffering an acute myocardial infarction. the investigators hypothesise that treatment with intracoronary abciximab, a potent anti platelet agent, at the time of coronary stent insertion, will improve microvascular function.

the index of microcirculatory resistance (imr), an invasive measure of coronary microvascular function, correlates with clinical outcomes in patients with stable angina and st elevation myocardial infarction. the glycoprotein iib/iiia receptor inhibitor, abciximab, improves coronary microvascular function and reduces major cardiac adverse events in patients with acute coronary syndromes. this study will investigate whether an intracoronary bolus of abciximab in patients with non-st elevation myocardial infarction decreases imr and improves microvascular function.

Eligibility criteria:
inclusion criteria: * patient with acute coronary syndromes exclusion criteria: * patient with untreated malignancy, disseminated malignancy, active inflammatory diseases, active infectious diseases patients unable to give informed consent patients with stemi
bank of biological material from patients and healthy donors for the study of urological and uro-oncological pathologies

Conditions: Urologic Diseases; Urologic Cancer; Infertility

Summary: the project aims to collect fresh biological material derived both from surgical resections performed in diseases, neoplastic and otherwise, of urological relevance at the level of the prostate, bladder, kidney, testicle and genitourinary organs, and from peripheral blood or other fluids biological samples such as urine, seminal fluid, buccal mucosa, feces or saliva, when available.

significant studies have shown the great potential of research based on access to biobanks which has made it possible to conduct studies and obtain important results through retrospective studies carried out on samples collected some time ago. thanks to the possibility of accessing human biological samples collected and stored in biological banks, great results have been achieved in the medical field. the project aims to collect fresh biological material deriving from surgical resections performed in neoplastic and non-neoplastic pathologies of urological relevance at the level of the prostate, bladder, kidney, testicle and genitourinary organs, both from biological samples of peripheral blood or other fluids such as urine, seminal fluid, buccal mucosa, feces or saliva, when available. the possibility of obtaining biological samples from the patient at the time of the first visit or the first biopsy and, subsequently, in conjunction with a possible surgical intervention, could ideally give the possibility of studying the disease from its possible onset to the possible intervention, evaluating the evolution and possible association with circulating diagnostic and prognostic markers. the establishment of this collection of research material will allow access to samples of extreme value for the pathophysiological study of the disease, its origin, mechanisms and markers of progression. the data obtained can also be correlated with the patient's clinical history in order to build an overall vision potentially useful in the design of new therapeutic strategies.

Eligibility criteria:
inclusion criteria: * male and female patients with an age \> 18 * ability to read and sign the informed consent * patients affected by urological or uro-oncological diseases exclusion criteria: * people with an age \< 18 * incapacity to read and sign the informed consent
effects of a movement training for subacromial pain syndrome

Conditions: Shoulder Impingement Syndrome

Summary: objectives: evaluate the effects of a rehabilitation program based on movement training on symptoms, functional limitations and acromiohumeral distance (ahd) in individuals with sps. methods: twenty-five participants with sps participated in a 6-week program. outcomes of both groups were evaluated at baseline and 6 weeks. changes in symptoms and functional limitations were assessed. changes in ahd for both groups were assessed using ultrasonographic measures.

background: multiple factors have been associated with the presence of a subacromial pain syndrome (sps), including deficits in performance of scapular and glenohumeral muscles. such deficits can lead to inadequate kinematics and decreased acromiohumeral distance (ahd). exercises that aim at correcting these deficits, such as movement training, were suggested to improve symptoms and functional limitations. to date, few studies have assessed outcomes following an intervention focused on movement training. objectives: evaluate the effects of a rehabilitation program based on movement training on symptoms, functional limitations and ahd in individuals with sps. design: prospective single group pre-post design. methods: twenty-five participants with sps (sps group) participated in a 6-week program. twenty asymptomatic volunteers were recruited for normative ahd values (control group). outcomes of both groups were evaluated at baseline and 6 weeks, i.e. immediately following intervention for the sps group. changes in symptoms and functional limitations for sps group were assessed using the western ontario rotator cuff index (worc) and disability of the arm shoulder and hand questionnaire (dash). changes in ahd for both groups were assessed using ultrasonographic measures.

Eligibility criteria:
inclusion criteria: * painful arc of movement during flexion or abduction * positive neer or kennedy-hawkins impingement signs * pain on resisted lateral rotation, abduction or empty can test. exclusion criteria: * previous shoulder surgery * shoulder pain reproduced by neck movement * clinical signs of full-thickness rc tears * shoulder capsulitis.

Keywords: shoulder rotator cuff rehabilitation motor control
pilot compassionate use study of thioctic acid treatment in mitochondrial myopathy

Conditions: Mitochondrial Myopathy

Summary: objectives: i. assess the efficacy of thioctic acid in treating a single patient with mitochondrial myopathy.

protocol outline: the patient receives one thioctic acid tablet 3 times a day. if patient experiences no side effects after 1 week, 2 tablets are administered and given 3 times a day over 3 months for compassionate use. the patient is followed at weeks 3, 8, and 12.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * long standing ophthalmoparesis and fatiguable weakness of the limbs * mild ataxia and no central nervous system involvement * history of mitochondrial dna deletion and a measurable biochemical defect of the respiratory chain * steady deterioration in skeletal muscle mass and power over 5 years --prior/concurrent therapy-- * previous participation in studies of muscle disease natural history (crc protocol 183a)

Keywords: inborn errors of metabolism mitochondrial myopathy rare disease
influence of abo blood group on the risk of complications in alcoholic or viral c cirrhosis?

Conditions: Alcoholic or Viral C Compensated Cirrhosis

Summary: the non-o blood group is a risk factor of deep vein thrombosis and recurrence of thromboembolic events, especially when associated with factor 5 leiden or prothrombin g20210a mutations. a recent study suggests that non-o blood group may promote portal vein thrombosis in non cirrhotic patients. in addition, in general population and chronic hepatitis c, non-o blood group combined with one or the other of the above genetic abnormalities is associated with an increased risk of liver fibrosis and accelerated fibrogenesis. the suspected mechanism could be an increased procoagulant factor viii and an increased willebrand plasma level, due to a low adamts 13 activity, the result of which is an hypercoagulable state and a microthrombotic process. in cirrhotic patients procoagulant factors and adamts 13 which are respectively increased and decreased, have be shown to be prognostic markers of hepatocellular function and portal hypertension. it has been hypothesized that the hypercoagulable state and the microthrombotic process could contribute to the worsening of the disease and enoxaparin has been shown to positively modify the prognosis of cirrhosis. the role of non-o blood group in decompensation of cirrhosis and occurrence of complications including non-tumor portal vein thrombosis has never been studied. the investigators plan a longitudinal observational study to determine the incidence of complications in alcoholic and viral cirrhosis in case of non-o blood group compared to o blood group. the aim of this study is to determine whether abo blood group may promote complications in alcoholic or viral cirrhosis. this is an ancillary study of two national cohorts assessing natural history and hepatocellular carcinoma risk factors in alcoholic (cirral) and viral (cirvir) cirrhosis.


Eligibility criteria:
inclusion criteria: * patient with either alcoholic or viral c cirrhosis included in national cohorts cirral and cirvir exclusion criteria: * those of cirral and cirvir with none tumoral portal thrombosis prior history